Details for New Drug Application (NDA): 206098
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The generic ingredient in ASENAPINE MALEATE is asenapine maleate. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the asenapine maleate profile page.
Summary for 206098
Tradename: | ASENAPINE MALEATE |
Applicant: | Alembic |
Ingredient: | asenapine maleate |
Patents: | 0 |
Suppliers and Packaging for NDA: 206098
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 206098 | ANDA | Alembic Pharmaceuticals Limited | 46708-198 | 46708-198-31 | 100 BLISTER PACK in 1 CARTON (46708-198-31) / 10 TABLET in 1 BLISTER PACK |
ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 206098 | ANDA | Alembic Pharmaceuticals Limited | 46708-198 | 46708-198-60 | 60 BLISTER PACK in 1 CARTON (46708-198-60) / 10 TABLET in 1 BLISTER PACK (46708-198-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Dec 10, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Dec 10, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | Jul 19, 2021 | TE: | AB | RLD: | No |
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